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日本肾移植受者中根据个体体重调整霉酚酸酯临床剂量的意义。

Implications of Clinical Mycophenolate Mofetil Dose According to Individual Body Weight in Japanese Renal Transplant Recipients.

作者信息

Yamada S, Shiohira H, Uehara H, Hokama N, Saitou S, Ooshiro Y

机构信息

Department of Hospital Pharmacy, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.

Department of Hospital Pharmacy, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan.

出版信息

Transplant Proc. 2016 Jan-Feb;48(1):35-41. doi: 10.1016/j.transproceed.2015.11.014.

Abstract

BACKGROUND

Mycophenolate mofetil (MMF) is generally administered at a fixed dose of 0.5-1.5 g/d without considering individual body weight (BW) in Japanese renal transplant outpatients receiving maintenance therapy. We aimed to investigate the implications of the area under the curve of mycophenolic acid (MPA AUC):MMF dose ratio by individual BW and suggest the index of MMF dose according to individual BW.

METHODS

Forty-three Japanese patients who received a renal transplant ≥6 months before the study were enrolled. Blood samples were collected at 4 time points: at predose, 20 minutes, 1 hour, and 3 hours after MMF administration.

RESULTS

The mean ± standard deviation MMF dose, MPA AUC, and BW of all patients were 581 ± 207 mg/d, 36.2 ± 18.7 μg·h/mL, and 56.3 ± 11.1 kg, respectively. Patients with a lower BW tended to have a higher MPA AUC:MMF dose ratio than patients with a higher BW. There was a significant correlation between the MMF dose:BW ratios and MPA AUC (r(2) = 0.330; P < .01). The rate of MPA AUC between 30 and 60 μg·h/mL with the MMF dose:BW ratio of 10-16 mg/kg was 73.7%.

CONCLUSION

Individual BW seems to affect the MPA AUC:MMF dose ratio; therefore, we need to consider individual BW when deciding on a MMF dose. The MMF dose:BW ratio of 10-16 mg/kg could predict MPA AUC between 30 and 60 μg·h/mL with a probability of approximately 75%. Therefore, it could be a useful index for outpatients, because it is difficult to draw blood frequently from such patients.

摘要

背景

在接受维持治疗的日本肾移植门诊患者中,霉酚酸酯(MMF)通常按0.5 - 1.5 g/d的固定剂量给药,而不考虑个体体重(BW)。我们旨在研究按个体体重计算的霉酚酸(MPA)曲线下面积与MMF剂量之比的意义,并根据个体体重提出MMF剂量指标。

方法

纳入43例在研究前≥6个月接受肾移植的日本患者。在MMF给药前、给药后20分钟、1小时和3小时这4个时间点采集血样。

结果

所有患者的平均±标准差MMF剂量、MPA曲线下面积和体重分别为581±207 mg/d、36.2±18.7 μg·h/mL和56.3±11.1 kg。体重较低的患者比体重较高的患者往往具有更高的MPA曲线下面积与MMF剂量之比。MMF剂量与体重之比和MPA曲线下面积之间存在显著相关性(r² = 0.330;P <.01)。MMF剂量与体重之比为10 - 16 mg/kg时,MPA曲线下面积在30至60 μg·h/mL之间的比例为73.7%。

结论

个体体重似乎会影响MPA曲线下面积与MMF剂量之比;因此,在决定MMF剂量时我们需要考虑个体体重。MMF剂量与体重之比为10 - 16 mg/kg时,MPA曲线下面积在30至60 μg·h/mL之间的概率约为75%,因此它可能是门诊患者的一个有用指标,因为这类患者频繁采血困难。

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